Clinical Research Operations Specialist
hace 2 semanas
We are seeking a highly skilled Clinical Research Operations Specialist to join our team at Novasyte. In this role, you will be responsible for overseeing the site activation process, ensuring compliance with local and international regulations, and providing exceptional support to investigative sites and project teams.
- Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
- Perform start-up and site activation activities according to applicable regulations, SOPs, and work instructions.
- Distribute completed documents to sites and internal project team members.
Our ideal candidate will possess strong written and verbal communication skills, excellent organizational and interpersonal skills, and the ability to reason independently and assess specific solutions in clinical settings. Additionally, they should have working knowledge of current ICH GCP guidelines and applicable regulations.
Requirements:- Bachelor's degree (or equivalent), preferably in science or related field.
- At least 6 months - 4 years relevant experience in study start-up and maintenance activities.
- Excellent verbal and written communication skills required in local language for assigned countries.
- Ability to work independently, prioritize, and work with a matrix team environment is essential.
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